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Extina

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Extina

Extina

INDICATIONS

Extina (ketoconazole foam, 2%) Foam is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of Extina (ketoconazole foam, 2%) Foam for treatment of fungal infections have not been established.

DOSAGE AND ADMINISTRATION

Extina (ketoconazole foam, 2%) Foam should be applied to the affected area(s) twice daily for four weeks. Hold the container upright, and dispense Extina (ketoconazole foam, 2%) Foam into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of Extina (ketoconazole foam, 2%) Foam with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that Extina (ketoconazole foam, 2%) Foam may be applied directly to the skin (rather than on the hair). Avoid contact with the eyes and other mucous membranes. Extina (ketoconazole foam, 2%) foam is not for ophthalmic, oral or intravaginal use.

Dosage Forms And Strengths

Extina (ketoconazole foam, 2%) Foam contains 2% ketoconazole in a thermolabile hydroethanolic foam, and is provided in 50 g and 100 g aluminum containers.

HOW SUPPLIED

Storage And Handling

Extina (ketoconazole foam, 2%) Foam, 2% is supplied in 50 g (NDC 63032-051-50) and 100 g (NDC 63032-051-00) aluminum containers. Store at controlled room temperature 68 - 77°F (20-25°C). Do not store under refrigerated conditions. Do not expose containers to heat, and/or store at temperatures above 120°F (49°C). Do not store in direct sunlight. Contents are flammable. Contents under pressure. Do not puncture and/or incinerate container.

Keep out of reach of children.

Patient Counseling Information

See FDA-approved patient labeling.

Instructions for Use

  • Avoid fire, flame and/or smoking during and immediately following application.
  • Do not apply Extina (ketoconazole foam, 2%) Foam directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips.

Local Reactions

  • Extina (ketoconazole foam, 2%) Foam may cause skin irritation (application site burning and/or reactions)
  • Extina (ketoconazole foam, 2%) Foam may cause contact sensitization.
  • As with any topical medication, patients should wash their hands after application.
  • Inform a physician if the area of application shows signs of increased irritation and report any signs of adverse reactions.

Manufactured For: Stiefel Laboratories, Inc., Coral Gables, FL 33134, USA
VersaFoam-HF is a trademark, and Extina (ketoconazole foam, 2%) , the V logo, and Stiefel are registered trademarks, owned by Stiefel Laboratories, Inc.
FDA rev date: 6/12/2007

Last reviewed on RxList: 7/9/2007
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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